FDA Roundup: January 23, 2024

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: 

• Today, the FDA announced the Medical Device Sterilization Town Hall: FDA Activities and Challenges in Reducing Reliance on Ethylene Oxide (EtO) that will be held on Jan. 26 from 12-1 p.m. ET. During this second in a series of medical device sterilization town halls, we will discuss the challenges and opportunities switching from EtO to other sterilization methods, the need for forward-looking collaborative activities to support reduced EtO use while assuring patients have access to medical devices, and the creation of a dedicated EtO Tiger Team to advance innovations in medical device sterilization. Registration is not required to attend. We encourage attendees to submit questions at least one week in advance to MedicalDeviceSterilization@fda.hhs.gov.
• On Monday, the FDA issued a marketing denial order to Bidi Vapor LLC for its Bidi Stick – Classic e-cigarette. After reviewing the company’s premarket tobacco product application, the FDA determined that the application lacked sufficient evidence to demonstrate that permitting marketing of the product would be appropriate for the protection of the public health, which is the standard legally required by the 2009 Family Smoking Prevention and Tobacco Control Act. Specifically, evidence submitted by the applicant did not demonstrate an overall net benefit to people who use tobacco products and lacks sufficient evidence to address health risks. The company may not market or distribute this product in the United States.
• On Friday, the FDA and the Centers for Disease Control and Prevention, in collaboration with Canadian, state and local partners, announced that the outbreak of Salmonella infections linked to recalled cantaloupe is over and the FDA investigation is complete. As part of this investigation, the FDA and industry partners worked together to collect and analyze samples of cantaloupe. Two of the samples were positive for Salmonella Sundsvall, and Whole Genome Sequencing analysis confirmed that the strain of Salmonella found in isolates associated with these two samples matched the same strain of Salmonella found in ill people. One isolate tested positive for Salmonella Newport; however, it was not associated with the outbreak. Industry’s cooperation in collecting and sharing samples with the FDA for further analysis provided additional information that helped resolve this outbreak.  
• On Friday, the FDA approved erdafitinib (Balversa, Janssen Biotech) for adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with susceptible FGFR3 genetic alterations, as determined by an FDA-approved companion diagnostic test, whose disease has progressed on or after at least one line of prior systemic therapy. Erdafitinib is not recommended for the treatment of patients who are eligible for and have not received prior PD-1 or PD-L1 inhibitor therapy. This approval amends the indication previously granted under accelerated approval for patients with mUC with susceptible FGFR3 or FGFR2 alterations after prior platinum-containing chemotherapy. View full prescribing information for Balversa.
• On Jan. 19, the FDA issued safety labeling change notification letters to all manufacturers of licensed BCMA-directed and CD19-directed genetically modified autologous CAR T cell immunotherapies requiring a revision to the package insert due to risk of T cell malignancies, with serious outcomes, including hospitalization and death. The FDA considers the serious risk of T cell malignancy to be applicable to all BCMA- and CD19-directed genetically modified autologous T cell immunotherapies. The letters notify manufacturers of each such licensed product to update the package insert to include available information related to the risks and to update the Medication Guide for these products to identify the possibility of the increased risk of getting cancers, including certain types of cancers of the immune system.

  In November 2023, the FDA posted a safety communication to provide information related to the receipt of reports of T-cell malignancies, including chimeric antigen receptor CAR-positive lymphoma, in patients who received treatment with BCMA- or CD19-directed autologous CAR T cell immunotherapies. Reports were received from clinical trials and/or postmarketing adverse event data sources. Although the overall benefits of these products continue to outweigh their potential risks for their approved uses, the FDA continues to investigate the identified risk of T cell malignancy with serious outcomes, including hospitalization and death.

  Patients and clinical trial participants receiving treatment with these products should be monitored life-long for new malignancies. In the event that a new malignancy occurs following treatment with these products, clinicians are encouraged to contact the manufacturer to report the event and obtain instructions on collection of patient samples for testing for the presence of the Chimeric Antigen Receptor transgene.

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